Modification Asahi New Pan-Series Hemofilters
FDA 510(k) K855251 · Advocacy International, Ltd.
510(k) numberK855251
Submission
- Device name
- Modification Asahi New Pan-Series Hemofilters
- Applicant
- Advocacy International, Ltd.
Washington, DC, US - Received
- December 30, 1985
- Decision date
- February 4, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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| K260533 | Elisio-HKDI · Special | Nipro Medical Corporation | 03/19/2026SE |
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| K253412 | Tablo Hemodialysis System (PN-0008000, PN-0006000U)KDI · Traditional | Outset Medical, Inc. | 01/26/2026SE |
| K253518 | FX CorAL 40; FX CorAL 50KDI · Special | Fresenius Medical Care Renal Therapies Group, LLC | 12/18/2025SE |
| K243920 | Purema H Hemoconcentrator - PediatricKDI · Traditional | Medica USA, Inc. | 09/19/2025SE |
| K250508 | AK 98 Dialysis Machine (955607)KDI · Traditional | Vantive US Healthcare, LLC | 08/01/2025SE |
| K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T…KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 06/13/2025SE |
| K243505 | 5008X Hemodialysis SystemKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/30/2025SE |
More from Fresenius Medical Care Renal Therapies Group, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K874027 | Lipase UV [Toyo]CHI · Traditional | 05/27/1988SE |
| K873792 | Sepacell R-500 and Sepacell R-500ACAK · Traditional | 01/19/1988SE |
| K855212 | Asahi Am Series DialyzersFJI · Traditional | 01/21/1986SE |
| K854259 | Sepacell R-500 & Sepacell R-500ACAK · Traditional | 01/08/1986SE |
| K842103 | Toyo Jozo Uric Acid TestKNK · Traditional | 08/12/1984SE |
| K842104 | Toyo Jozo G-Gtp TestJPZ · Traditional | 08/10/1984SE |
| K830231 | Asahi Hollow Fiber Kidneys, Am-SeriesKOC · Traditional | 03/17/1983SE |
| K830183 | Asahi Hollow Fiber Kidneys NR SeriesKOC · Traditional | 03/17/1983SE |
| K823733 | Eiken Kizai Artificial Kidney Blood CirKOC · Traditional | 01/14/1983SE |
| K813037 | Flowguard Catheters & CannalaeDWF · Traditional | 12/14/1981SE |
Questions and answers
When was Modification Asahi New Pan-Series Hemofilters cleared by the FDA?
Modification Asahi New Pan-Series Hemofilters (K855251) received a 510(k) decision of Substantially Equivalent on February 4, 1986, 36 days after the submission was received.
What is the product code of K855251?
The FDA product code is KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System, a Class II (moderate risk) device regulated under 21 CFR 876.5860.